2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium acetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Final Report on the Safety Assessment of test chemical

Author:

Cosmetic Ingredient Review Expert Panel

Year:

1986

Bibliographic source:

JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, Volume 5, Number 3, 1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Kligman-Magnusson procedure

Principles of method if other than guideline:

The dermal sensitization potential of the test chemical was assessed in guinea pigs using the Kligman – Magnusson procedure

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[[4-[(4-aminophenyl)azo]phenyl]imino]bisethanol

EC Number:

243-987-5

EC Name:

2,2'-[[4-[(4-aminophenyl)azo]phenyl]imino]bisethanol

Cas Number:

20721-50-0

Molecular formula:

C16H20N4O2

IUPAC Name:

2,2'-[[4-[(4-aminophenyl)azo]phenyl]imino]bisethanol

Test material form:

solid: particulate/powder

Details on test material:

Name of the test chemical: 2,2'-[[4-[(4-aminophenyl)azo]phenyl]imino]bisethanol
Common Name: Disperse Black 9
Molecular Formula: C16H20N4O2
Molecular Weigth:300.36 g/mol
Substance Type:Organic
Physical State: Solid (orange powder)

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

petrolatum

Concentration / amount:

Intradermal exposure:
Three pairs of injections (0.05 ml each) were administered intradermally- Freund’s complete adjuvant (in equal parts water), 0.1% test chemical, and a mixture of equal parts of the adjuvant and dye.

Day(s)/duration:

48 hours

Adequacy of induction:

not specified

Induction 2

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

25% in petrolatum

Day(s)/duration:

48 hours

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

propylene glycol

Concentration / amount:

25% in propylene glycol

Day(s)/duration:

48 hours

Adequacy of challenge:

not specified

No. of animals per dose:

10 female Hartley guinea pigs

Details on study design:

RANGE FINDING TESTS:No data available

MAIN STUDY
A. INDUCTION EXPOSURE
(intradermal exposure)
- No. of exposures: Three pairs of intradermal injections
- Exposure period:no data
- Test groups:10
- Control group:No data available
- Site: intrascapular region
- Frequency of applications:No data available
- Duration:No data available
- Concentrations: Three pairs of injections (0.05 ml each) were administered intradermally- Freund’s complete adjuvant (in equal parts water), 0.1% test chemical, and a mixture of equal parts of the adjuvant and dye

(Epicutaneous, occlusive)
- No. of exposures: single
- Exposure period: 48 hours
- Test groups: 10 female Hartley guinea pigs
- Control group: no data
- Site: intrascapular area
- Frequency of applications: single
- Duration: 48 hours
- Concentrations: 25% in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge:No data available
- Exposure period:No data available
- Test groups:10 guinea pigs
- Control group:No data available
- Site: flank
- Concentrations: 25% in propylene glycol
- Evaluation (hr after challenge): Sites were evaluated 24, 48, and 72 hours after patch removal.

OTHER: no data available

Challenge controls:

no data available

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25% in propylene glycol

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Skin sensitizing effects were not observed.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

No signs of dermal sensitization were observed on female guinea pig skin at any time point after challenge exposure.
Hence, the test chemical was considered to be not sensitizing to guinea pig skin.

Executive summary:

The dermal sensitization potential of the test chemical was assessed in guinea pigs using the Kligman – Magnusson procedure.10 female Hartley guinea pigs were used for the study.

Three pairs of injections (0.05 ml each) were administered intradermally into the shaved interscapular area of each guinea pig: Freund’s complete adjuvant (in equal parts water), 0.1% the test chemical, and a mixture of equal parts of the adjuvant and dye. One week later, the sites were shaved again, and a 48-h occlusive patch containing 25% test chemical in petrolatum was applied. Two weeks later, an occlusive challenge patch containing 25% test chemical in propylene glycol was applied to the shaved flank of each guinea pig. Sites were evaluated 24, 48, and 72 hours after patch removal.

No signs of dermal sensitization were observed on female guinea pig skin at any time point after challenge exposure.

Hence, the test chemical was considered to be not sensitizing to guinea pig skin.